Diatrizoate Meglumine and Diatrizoate Sodium

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGuardian Drug Company

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5304168803
120 mL in 1 BOTTLE, PLASTIC (53041-688-03)

Annotations

UNII (FDA Substance ID)

3X9MR4N98U

DIATRIZOATE MEGLUMINE

RxCUI 3320

Orange Book

A214201

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3X9MR4N98U",
    "rxcui": "3320",
    "inchikey": "MIKKOBKEXMRYFQ-WZTVWXICSA-N",
    "display_name": "DIATRIZOATE MEGLUMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL; RECTAL",
  "spl_meta": {
    "a216a7d5-3c28-482b-956a-93ae146e3763": {
      "match": "brand_token",
      "title": "DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) SOLUTION [CAMBER PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2025-02-21"
    }
  },
  "productid": "53041-688_9cfdb214-1075-4449-9a01-f04cf5d0edfe",
  "productndc": "53041-688",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "214201",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "66%;10%",
        "product_no": "001",
        "approval_date": "Jun 27, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM",
  "proprietary_name": "Diatrizoate Meglumine and Diatrizoate Sodium",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA214201",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diatrizoate Meglumine and Diatrizoate Sodium",
  "start_marketing_date": "20191218",
  "active_numerator_strength": "660; 100"
}

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